BICOE – Stereotactic Breast Biopsy and
Breast Ultrasound Accreditation
William Geiser, MS DABR
Senior Medical Physicist
MD Anderson Cancer Center
Houston, Texas
wgeiser@mdanderson.org
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Introduction
• Objectives
• Program Requirements
• Physicists Role
• Testing Requirements
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Educational Objectives
• Understand the annual test requirements for
stereotactic breast biopsy systems.
• Understand the testing requirements for
breast ultrasound systems for BICOE.
• Help facilities obtain the designation of
Breast Imaging Center of Excellence.
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What is it? - Requirements
• ACR Accreditation in:
– Mammography – ACR or State Accreditation
– Stereotactic Breast Biopsy
– Ultrasound
• Must include ultrasound guided breast biopsy
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Physicists Role
• Mammography Accreditation
– Annual testing (required)
– QC Program Review (required)
– Dose Measurement (required)
• Stereotactic Breast Biopsy Accreditation
– Annual Testing (required)
– QC Program Review (required)
– Dose Measurement (required)
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Physicists Role
• Ultrasound Accreditation (by June 2014)
– The ACR strongly recommends that QC be
done under the supervision of a qualified
medical physicist. The qualified medical
physicist may be assisted by properly trained
individuals in obtaining data, as well as other
aspects of the program
– Annual testing (required)
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MQSA Physicist
• Initial Requirements
– Mammography – MQSA
– Stereotactic Breast Biopsy – ACR
– Ultrasound - None
• Continuing requirements
– Mammography – MQSA
– Stereotactic Breast Biopsy – ACR
– Ultrasound - None
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Stereotactic Breast Biopsy Physicist
• Initial Qualifications
– Qualified to perform Mammography surveys under MQSA
– Perform one (1) hands on survey of a stereotactic breast biopsy unit
under a QMP or at least 3 independent surveys prior to 6/1/97
• Continuing Experience
– Upon renewal 2 SBB surveys over a 24 month period
• Continuing Education
– Upon renewal 3 CEU’s in SBB every three years
Ref: http://www.acr.org/accreditation/stereotactic/stereotactic_breast_reqs.aspx
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What are the minimum continuing experience requirements
for the physicist performing stereotactic breast biopsy system
surveys for the ACR Accreditation program?
0%
1.
1 stereotactic breast biopsy survey over a 12 month
period
0%
2.
2 stereotactic breast biopsy surveys over a 24
month period
0%
3.
3 stereotactic breast biopsy surveys over a 24
month period
0%
4.
3 stereotactic breast biopsy surveys over a 36
month period
5.
4 stereotactic breast biopsy surveys over a 36
month period
0%
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Answer
2. 2 stereotactic breast biopsy surveys over a
24 month period
Ref: Stereotactic Breast Biopsy Program Requirements:
American College of Radiology
http://www.acr.org/accreditation/stereotactic.aspx
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Ultrasound - Physicist
• Still no requirements listed!
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Stereotactic Breast Biopsy Program
Requirements
• Quality Assurance Questionnaire
• Test Image Data Sheet
• Dosimeter
• Clinical Images (on film)
• Phantom Images (on film)
• Medical Physicists Annual Survey Report
• Daily, Weekly Tech QC (one month)
• Monthly, Quarterly, Semi-annual Tech QC records
(one year)
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Technologist Quality Control
• Daily – Localization Accuracy
Test
• Phantom Imaging (weekly)
• Printer QC (monthly)
• Visual Checklist (monthly)
• Compression (semi-annually)
• Repeat Analysis (quarterly)
• Zero Alignment Test (per
manufacturer)
• Dark Room Testing (if using
film screen)
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Daily Localization Accuracy Test
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Upright Stereo Biopsy
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Stereotactic Breast Biopsy
– Annual testing required
by physicist
– ACR QC Manual
available
Ref: Stereotactic Breast Biopsy Quality Control Manual
1999 American College of Radiology
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Stereotactic Breast Biopsy Annual Test –
Prone Table
• Unit Assembly Evaluation
• Collimation Assessment
• Focal Spot Performance and System Limiting
Spatial Resolution
• kVp Accuracy
• Beam Quality Assessment (Half Value Layer)
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Stereotactic Breast Biopsy Annual Test –
Prone Table
• Automatic Exposure Control(AEC) or Manual
Exposure Assessment
• Uniformity of Screen Speed (Screen Film
Systems)
• Digital Receptor Uniformity (For Digital Image
Receptors)
• Breast Entrance Exposure, Average Glandular
Dose, and Exposure Reproducibility
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Stereotactic Breast Biopsy Annual Test –
Prone Table
• Image Quality Evaluation
• Artifact Evaluation
• Localization Accuracy Test
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Stereotactic Breast Biopsy Annual Test –
Upright Add On
• Unit Assembly Evaluation
• Beam Quality Assessment (Half Value Layer)
– With paddle and at kVp for stereo phantom
• Breast Entrance Exposure, Average Glandular
Dose
• Image Quality Evaluation (with mini phantom)
• Localization Accuracy Test
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Unit Assembly Evaluation
• Mechanically Stable
• Technique charts
• Moving parts
– 512/1024 modes
• Locks/Detents
• Radiation shielding
• Image receptor no
vibes
• Needle guides support
needle
• Compressed breast
thickness indicator
• No rough edges
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Collimation
CR Image
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Collimation
If any edge of radiation field deviates more than 5 mm from the edge of
the image receptor, or if any edge of the compression paddle projects
into the X-ray field by more than 5 mm, then seek service adjustment.
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What is the maximum allowable alignment
deviation of the radiation field edge to the
image receptor for a stereotactic breast biopsy
system?
1. 1 mm
0%
2. 2 mm
0%
3. 3 mm
0%
4. 4 mm
0%
5. 5 mm
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Answer
• 5. 5 mm
Ref: Stereotactic Breast Biopsy Quality
Control Manual 1999, Medical Physicist
Section, Collimation Assessment, American
College of Radiology
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Focal Spot Performance and System
Limiting Resolution
Action Limit: Note any significant degradation from previous measurement and seek
service.
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kVp
Action Limit: If the mean kVp differs from the nominal
by more than +/- 5% of the nominal kVp, or if the
coefficient of variation exceeds 0.02, then seek service
correction
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Beam Quality – Half Value Layer
• HVL ≥ kVp/100
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Automatic Exposure Control (AEC)
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Technique Chart
Breast
Thickness
Exposure
Mode
kVp Setting
Density
Control
Setting
Phototimed
(Yes or No)
< 3 cm
512
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N/A
Yes
3 to 5 cm
512
28 - 30
N/A
Yes
5 to 7 cm
512
30 - 32
N/A
Yes
> 7 cm
512
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N/A
Yes
Breast
Thickness
Exposure
Mode
kVp Setting
Density
Control
Setting
Phototimed
(Yes or No)
< 3 cm
1024
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N/A
Yes
3 to 5 cm
1024
30 - 32
N/A
Yes
5 to 7 cm
1024
> 7 cm
1024
32 - 34
N/A
Yes
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N/A
No – 400 mAs35
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AEC Performance
• Select kVp
• Use AEC and make
exposure
• Measure mean pixel
value in center of field
• Meet manufacturers
specifications
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AEC
• Ideally, clinical techniques (whether AEC or
manual) should keep exposure times under
2 seconds while meeting manufacturers
signal requirements
Ref: Stereotactic Breast Biopsy Quality Control Manual 1999
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Digital Field Uniformity
Both 512 and 1024 modes
• Action Limit: If SNR(I) /
SNR(Center) is > 1.15 or
< 0.85, seek service
correction.
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Digital Field Uniformity
• May require manufacturers service manual
for procedure.
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Breast Entrance Exposure Average Glandular
Dose, and Exposure Reproducibility
• Use AEC to expose Phantom
• Find closest manual technique
• Replace phantom with ion chamber
• Make 4 exposures
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Dose
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Dose
• We check both 512 and 1024 modes
• Made change to technique chart to get 1024
mode to be less than 300 mrad
• “The average glandular dose to an average
(4.2 cm compressed) breast should not
exceed 3 mGy (300 mrad) per view for filmscreen or digital image receptors”
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Technique Chart
Breast
Thickness
Exposure
Mode
kVp Setting
Density
Control
Setting
Phototimed
(Yes or No)
< 3 cm
512
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N/A
Yes
3 to 5 cm
512
28 - 30
N/A
Yes
5 to 7 cm
512
30 - 32
N/A
Yes
> 7 cm
512
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N/A
Yes
Breast
Thickness
Exposure
Mode
kVp Setting
Density
Control
Setting
Phototimed
(Yes or No)
< 3 cm
1024
28
N/A
Yes
3 to 5 cm
1024
30 - 32
N/A
Yes
5 to 7 cm
1024
> 7 cm
1024
32 - 34
N/A
Yes
34
N/A
No – 400 mAs44
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What is the maximum allowable dose per
view to a 4.2 cm compressed breast as
recommended by the ACR?
0%
1. 1.5 mGy
0%
2. 2.0 mGy
0%
3. 2.5 mGy
0%
4. 3.0 mGy
0%
5. 3.5 mGy
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Answer
4. 3.0 mGy
Ref: Stereotactic Breast Biopsy Quality
Control Manual, Medical Physicist Section
Breast Entrance Exposure, Average
Glandular Dose, and Exposure
Reproducibility
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Image Quality Evaluation
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Required Minimum Scores-Film Screen
• Mammography
Accreditation Phantom
– 4.0 Fibers
– 3.0 Specs
– 3.0 Masses
• Mini-phantom
– 2.0 Fibers
– 2.0 Specs
– 2.0 Masses
– Total: 6.0
– Total: 10.0
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Required Minimum Scores - Digital
Receptor
• Mammography
Accreditation Phantom
– 5.0 Fibers
– 4.0 Specs
– 3.5 Masses
• Mini-phantom
– 3.0 Fibers
– 3.0 Specs
– 2.5 Masses
– Total: 8.5
– Total: 12.5
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What are the minimum scores for a
digital receptor when using the miniphantom?
0%
1. 1.0 Fibers, 1.0 Spec groups, 1.0 Masses
0%
2. 2.0 Fibers, 2.0 Spec groups, 2.5 Masses
0%
3. 3.0 Fibers, 3.0 Spec groups, 2.5 Masses
0%
4. 3.5 Fibers, 3.5 Spec groups, 3.0 Masses
0%
5. 4.0 Fibers, 4.0 Spec groups, 4.0 Masses
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Answer
• 3. 3.0 Fibers, 3.0 Spec groups, 2.5 Masses
• Ref: Stereotactic Breast Biopsy Quality Control
Manual, Medical Physicist Section Image Quality
Evaluation
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Artifact Evaluation
• Note any artifacts or
non-uniformities in the
field.
• Both 512 and 1024
modes
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Localization Accuracy Test
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Localization - Prefire
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Localization - Postfire
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Add On Biopsy Systems
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Beyond Annual Mammo Testing
• HVL at Phantom kVp with Stereo Paddle
• HVL Measurement for Tomo Biopsy
• Dose Measurement for Phantom for Both
• Image Quality with Stereo Phantom
• Localization
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HVL - Upright Stereo Add On
Aluminum
Ion Chamber
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Tomosynthesis Guided Biopsy
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Tomosynthesis Guided Biopsy
• FDA approved
• No ACR Accreditation Program
• No Manufacturers QC Program
– Do what you think is best
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Breast Ultrasound Accreditation
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Requirements prior to June 2014
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Changes to Breast Ultrasound Program –
Effective June 2014
• Acceptance Testing
• Quality Control Tests
• Annual Survey
S:\AccredMaster\Umbrella Program\Application DMAP
V2\overview_reqs\reqs\breast_ultrasound_reqs_5-29-13.DOCX
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Acceptance Testing
• Initial performance testing of newly
installed imaging equipment must be
performed and should be completed before
clinical use
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Continuing Quality Control
• A continuous QC program is essential to assure the proper
functioning of all ultrasound equipment and to identify
problems before the diagnostic utility of the equipment is
significantly impacted7,8. Routine QC is typically
performed by appropriately trained sonographers or
equipment service engineers.
• In addition to testing done for the annual survey, all
scanners and all transducers in routine clinical use should
be tested quarterly, but must be tested at least semiannually.
–
–
7. Mårtensson M, Olsson M, Brodin LÅ. Ultrasound transducer function: annual testing is not sufficient. Eur J
Echocardiogr. 2010 Oct;11(9):801-5.
8. Hangiandreou NJ, Stekel SF, Tradup DJ, Gorny KR, King DM. Four-year experience with a clinical
ultrasound quality control program. Ultrasound Med Biol. 2011 Aug;37(8):1350-7.
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5 Tests for the Technologist
1. Physical and Mechanical Inspection
2. Image Uniformity and Artifact Survey
3. Geometric Accuracy (mechanically scanned
transducers only)
4. Ultrasound scanner Electronic Display
Performance
5. Primary Interpretation Display Performance*
– Only required if located at the facility where ultrasound is
performed
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Annual Survey
• The QC tests listed in the table below are
required (unless they are designated as
optional) and must be performed at least
annually on all machines and transducers in
routine clinical use.
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Program Requirements – Annual Survey
• Physical and Mechanical Inspection
• Image Uniformity and Artifact Survey
• Geometric Accuracy
• System Sensitivity
• Ultrasound Scanner Electronic Image
Display Performance
• Primary Interpretation Display
Performance*
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Program Requirements – Annual Testing
• Contrast Resolution (Optional)
• Spatial Resolution (Optional)
• Evaluation of QC Program
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Starting June 2014 what is the recommended
frequency for equipment surveys of
ultrasound equipment for the ACR’s breast
ultrasound accreditation program?
0%
1. Quarterly
0%
2. Semiannually
0%
3. Annually
0%
4. Every other year
0%
5. None
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Answer
• 3. Annually
Ref: Stereotactic Breast Biopsy Accreditation
Program Requirements
http://www.acr.org/accreditation/breast.aspx
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Electrical – Mechanical Condition
• Power cord
• Wheel Locks, Brakes
• Housing
• Scan Head Cable, Plugs
• Scan Head Housing, Window
• Monitor
• Air Filters
• VCR
• Printer Function
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System Sensitivity – Depth of Pen
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Uniformity and Artifacts
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Vertical Distance Accuracy
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Horizontal Distance Accuracy
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Anechoic Void Perception
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Ring Down – Dead Zone
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Lateral Resolution
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Axial Resolution
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Evaluation of Sites QC Program
• Review semiannual QC results
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Questions?
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